This drug should not be used during pregnancy unless the benefit to mother outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk summary:
-No data available on use of this drug in pregnant women to inform a drug-related risk. However, based on animal studies, malformative risk with the use of this drug in pregnant women is likely.

Comments:
-Effective contraception is recommended for females of reproductive potential during therapy and for 14 days after the last dose.
-Verify the pregnancy status in females of reproductive potential before beginning therapy.
-The patient should be apprised of the potential harm to the fetus.

In an embryo-fetal toxicity study in pregnant mice, exencephaly was observed in offspring at an exposure less than the exposure at the maximum recommended human dose (MRHD) of this drug. Embryonic exposure to sphingomyelin metabolites or a sphingosine-1-phosphate (S1P) receptor modulator produced neural tube defects causing exencephaly in chicks and mice. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

This drug was administered to lactating mice on post-partum day 7, and its presence in milk was evaluated on day 9. The concentration detected was approximately 1.3% of the estimated maximal maternal plasma concentration.

Safety has not been established.

Excreted into human milk: Data not available
Excreted into animal milk: Yes

Comments:
-When a drug is present in animal milk, it is likely that the drug will also be present in human milk.

See references